Method and apparatus for accurately deploying particular medical appliances at a target site

ABSTRACT

The present invention regards system, method, and apparatus for selectively and accurately deploying one or more sequentially positioned medical appliances from a portable medical device. An apparatus, in accord with one embodiment of the present invention, includes a ligation tip having an internal passage and an outside surface wherein the outside surface has a plurality of sequentially ordered deployable medical appliances in contact with it. The apparatus also includes a body having a channel in communication with the internal passage of the ligation tip, a string passing through the internal passage and the channel, and a means, coupled to the string, for affirmatively verifying that a specific medical appliance, from the plurality of sequentially ordered medical appliances, has been deployed from the ligation tip.

RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication Ser. No. 60/226,901, filed Aug. 23, 2000, and incorporatesthat application herein, in its entirety, by reference.

FIELD OF THE INVENTION

[0002] The present invention generally relates to method and apparatusfor the performance of medical procedures at a target site remote fromthe medical practitioner performing the procedure. More particularly thepresent invention relates to method and apparatus for accuratelydeploying particular medical appliances from a medical device after themedical device has been positioned at a site targeted to receive themedical appliance.

BACKGROUND INFORMATION

[0003] Medical procedures may be performed by a practitioner throughdirect contact and interface with a target site as well as throughremote access to the target site via medical devices, such asendoscopes, which are designed to extend the practitioner's reach. Byextending the practitioner's 's reach these devices allow some medicalprocedures, previously performed only through invasive procedures, to beperformed through non-invasive methodologies. One drawback of theseextension devices and remote access methodologies is that a practitionermay not be able to watch the procedure being performed and, thus, maynot be able to visually determine if the procedure he is performing hasbeen properly completed.

[0004] For instance, when an endoscope is being used for the ligation ofa polyp deep within a patient's body, the distal end of the endoscope,where the procedure is actually carried out, is not directly visible tothe practitioner. Nevertheless, despite this handicap, the practitionermust first maneuver the distal end of the endoscope to the targetedpolyp and then, in less sophisticated systems, must perform theprocedure relying solely on his or her own tactile abilities. In oneendoscopic ligation unit this process would involve pulling on a singlestring emerging from the proximal end of the endoscope until one of theseveral bands, which the string was wrapped around at its distal end,was deployed. In this unit, if the string was pulled too far, more thanone band may be deployed and, if the string was not pulled far enough, aband may not be deployed at all. During its use, once the practitionerthought that a single band was deployed, but without positiveconfirmation, the practitioner would relocate the distal end of theendoscope to deploy another band or if the procedure was completed,retract the endoscope from the patient.

[0005] If the ligation bands had become entangled during the procedurethey could remain on the distal end of the ligation unit and providenotice to the practitioner, upon the endoscope's removal, that theprocedure was not properly performed. Conversely, if too many bands weredeployed during the procedure or if they were deployed in the wrongareas, it would be difficult if not impossible for the practitioner toimmediately discern, based on viewing the distal end of the ligationunit, that the bands had been improperly deployed from the endoscope.

SUMMARY OF THE INVENTION

[0006] The present invention regards system, method, and apparatus forselectively and accurately deploying one or more sequentially positionedmedical appliances from a portable medical device. An apparatus, inaccord with one embodiment of the present invention, includes a ligationtip having an internal passage and an outside surface wherein theoutside surface has a plurality of sequentially ordered deployablemedical appliances in contact with it. The apparatus in this embodimentalso includes a body having a channel in communication with the internalpassage of the ligation tip, a string passing through the internalpassage and the channel, and a means, coupled to the string, foraffirmatively verifying that a specific medical appliance, from theplurality of sequentially ordered medical appliances, has been deployedfrom the ligation tip.

[0007] A system for selectively deploying one or more sequentiallypositioned medical appliances from a portable medical device to a targetsite is provided in an alternative embodiment of the present invention.This system may include a flexible sheath having a channel, an insidesurface, an outside surface, a distal end, and a proximal end. Inaddition, this sheath may contain a plurality of strings positionedwithin its channel wherein each string may have a first end and a secondend, wherein the first end of at least one string may be coupled to apull that has a unique marking, and wherein the second end of the stringthat is coupled to the unique marking may be in physical communicationwith a catch. The system in this embodiment may also include an externalsealing plug positioned along the outside surface of the sheath betweenthe sheath's distal end and proximal end, wherein the plug has a passagesized to slidably couple the sheath to it.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]FIG. 1 is side perspective view of a removeable string systemcontaining a plurality of strings prior to its insertion into a body inaccord with one embodiment of the present invention.

[0009]FIG. 2 is a side perspective view of the removeable string systemcontaining a plurality of strings from FIG. 1 after it has been insertedinto the body in accord with one embodiment of the present invention.

[0010]FIG. 3 is a side perspective view of the removeable string systemcontaining a plurality of strings from FIG. 1 after it has been insertedinto the body and after the strings have been connected to the filamentsof the ligation tip in accord with one embodiment of the presentinvention.

[0011]FIG. 4 is a side perspective view of one of the strings, from theplurality of strings, being pulled in order to deploy a ligation band inaccord with one embodiment of the present invention.

[0012]FIG. 5 is a side perspective view of a medical apparatus in accordwith one embodiment of the present invention.

[0013]FIG. 6 is a side perspective view of the medical apparatus fromFIG. 5 being used by a practitioner in accord with one embodiment of thepresent invention.

[0014]FIG. 7 is a side perspective view of a medical apparatus in accordwith one embodiment of the present invention.

DETAILED DESCRIPTION

[0015] FIGS. 1-4 illustrate the components, assembly, and use of amedical device or apparatus that may be used to deploy ligation bands orother medical appliances within the body of a patient in accord with oneembodiment of the present invention. The medical device depicted inthese figures may be used independently or in conjunction with anendoscope or other device to perform endoscopic tubal ligations as wellas numerous other procedures.

[0016]FIG. 1 is a side perspective view of some of the components of themedical device that is depicted in FIGS. 1-4 (wherein like elements havebeen numbered throughout with like numerals). FIG. 1 illustrates theremovable cable system 10 prior to its insertion into the y-extensionextension 103 of tube or body 19 which may be an endoscope or any otherdevice capable of creating an operating channel to a target site in thepatient in accord with one embodiment of the present invention. As canbe seen, this removable cable system 10 contains a plurality offilaments or strings 13 running through a flexible sheath 11. The sheath11, which may be made from rubber, plastic or any other flexible andresilient material, may have a circular, hexagonal, octangular or othercross-sectional shape. However, regardless of which cross-sectionalshape is used, it is preferable that the cross-sectional area be sizedsuch that the sheath 11 may readily encase each of the strings 13traveling through it, that the strings may not be bound within thesheath 11, that the strings 13 may be readily pulled back and forththrough the sheath 11 and that the sheath 11 containing the strings 13may be sized to fit within the body 19 and the y-extension extension 103of the body 19.

[0017] The system 10 of FIG. 1 may also include a sealing plug 18 havinga bore 102 traveling through it wherein the bore 102 is sized to allowthe sheath 11 to slide back and forth within it. This sealing plug 18may be made from the same material as the sheath 11 or it may be madefrom a separate material. It may also be manufactured in conjunctionwith the sheath 11 or it may be placed around the sheath 11 after thesheath 11 has been manufactured. Moreover it may be added to the sheatheither before and after the strings have been placed within the sheath11.

[0018] The external sealing plug 18 may have a tang portion 101, asillustrated in FIG. 1, that is sized to frictionally secure the sealingplug 18 to the y-extension 103 of the body 19. When the tang portion 101is inserted into the y-extension 103 the system 10 may continue to beable to slide in and out of the body 19 due to the size of the bore 102in relation to the sheath 11. In an alternative configuration, ratherthan using friction to secure the tang 101 to the y-extension 103 thetang portion 101 may contain threads that may be used to secure thesealing plug 18 to the body 19. Moreover, in addition to thisalternative configuration other securement configurations andmethodologies, such as bendable clips and adhesives, may also be used tosecure the sealing plug 18 to the y-extension 103 of the body 19.

[0019] The sheath 11 may also have a stopper 17 positioned on itsoutside surface. This stopper 17 may be made in conjunction with thesheath 1 1 or may be added at a later time. This stopper 17 ispreferably fixedly secured to the sheath 11 and sized to prevent thesheath 11 from being completely slid through the bore 102 of the sealingplug 18.

[0020] The strings 13, which are located within the sheath 11, may havepulls 15 attached to one of their ends. These pulls 15 may have uniqueidentifiers or tags 14 attached to them which act, with the pulls 15, asa means for affirmatively verifying that the specific medical appliancefrom a plurality of medical appliances, has been deployed.Alternatively, rather than using a pull and tag system the pulls 15 may,themselves, be colored or otherwise identified to allow them to beeffectively distinguished from one another.

[0021] The opposite end of the strings 13, (i.e. those not coupled tothe pulls 15) may terminate in a loop or catch 16 or may at least be inphysical communication with the loop or catch 16. This catch 16 may beused, as shown in FIG. 3, to releasably connect the individual strings13 of the system 10 to hooks 20 associated with individual ligatingbands that surround the ligation tip 30 in FIG. 3 and may be deployed bypulling on the pulls 15 during a medical procedure.

[0022] As can be seen in FIG. 2 the removeable cable system 10 may beinserted into the y-extension extension 103 of the body 19 until thetang 101 of the sealing plug 18 comes to rest within the end of they-extension 103. As can also be seen in this figure the sheath 11 andthe strings 13 are sized such that when the sealing plug 18 comes torest against the y-extension 103 of the body 19 the catches 16 extendpast the distal end 22 of the body 19. By sizing the sheath 11 andstrings 13, so that they are longer than this portion of the body 19,the catches 16 may be readily attached to hooks 20 of the ligation tip30 shown in FIG. 3.

[0023]FIG. 3 illustrates a side view of the medical device from FIGS.1-4 after the individual filaments 33 of the ligation tip 30 have beencoupled to the strings 13 of the cable system 10. As indicated by arrow36, once the requisite connections have been made between the filaments33 and the strings 13, the end 32 of the ligation tip 30 may be slidaround or into the open end 22 of the body 19. At the same time, toprevent the strings 13 and the filaments 33 from becoming entangled, thecable system 10 may be pulled, as indicated by arrow 34, to remove anyslack in the lines created by the insertion and coupling process. As canbe seen, the stopper 17 may act to limit the distance that the cablesystem 10 may be pulled through the sealing plug 18, and, thereby,prevent the premature deployment of all of the ligating bands from thetip 30 as would occur if the removable cable system 10 was pulled toofar back up through the sealing plug 18.

[0024] The ligation tip 30, which is fully evident in FIG. 4, maycontain a plurality of ligation bands 31 that may be located around itsoutside surface. These ligation bands 31 may be individually coupled tothe individual filaments 33 which are in turn individually coupled tothe strings 13. Thus, in use, as depicted in FIG. 4, by pulling on oneof the pulls 15 as indicated by arrow 42 a specific ligation band 31 maybe deployed from the ligation tip 30 as indicated by arrow 41. Becauseeach pull 15 has a unique marking to associate it with a specificdeployable medical appliance, when an operator pulls a specificallymarked pull, the operator will know which medical appliance, in thiscase a ligation band, is being deployed at that time. Thus, through thissystem, a practitioner may more accurately control the deployment ofligation bands from the distal end of a ligation unit as he canpositively determine, from the proximal end of the device, whichligation band is being deployed

[0025]FIG. 5 is a side perspective view of an alternative embodiment ofthe present invention. In FIG. 5 a means 50 for affirmatively verifyingthat at medical appliance from a plurality of medical appliances, hasbeen deployed can be seen. This means 50 may be attached to an endoscopeas illustrated in FIG. 6. This means 50 may contain a plunger 52, a body56, a string 53, and a variable length string passageway 51 and may beused to deploy ligation bands or other medical appliances located at thedistal end of an endoscope. This means 50 accomplishes this task byshortening or otherwise pulling on a string contained within thepassageway 51 that is coupled to a plurality of deployable medicalappliances at the distal end of the endoscope. This string is pulled orshortened by a specific predetermined distance by depressing one of theplungers 52 of the means 50. As the plunger 52 is depressed, the string53 resident in the passageway 51 and coupled to anchoring point 57 willhave its effective length shortened by the distance that it must nowtravel around the depressed plunger 52. Thus, by depressing the plunger52, the string will be shortened and a ligation band or other devicecoupled to the string may be deployed by the medical device.

[0026] A specific method of using the means 50 from FIG. 5 may includecoupling the body 56 to an endoscope and then treading a string 53through the string passageway 51 and anchoring point 57. The distal endof the string 53 may then be threaded around each deployable medicalappliance in sequential order. Then, as mentioned above, in order todeploy the medical appliance, the plunger 52 may be depressed, in orderto draw the string 53 into the valley 58 associated with the plunger 53thus altering the string's pathway and shortening its effective length.Consequently, when a plunger 52 is depressed, a medical appliancecoupled to the string's distal end may be deployed from the distal endof the medical device. If a second medical appliance is to be deployed,a second plunger may be depressed while the first plunger is alsodepressed. Here, the effective length of the string will be twiceshortened and the second medical appliance may be deployed. Likewise athird appliance may also be deployed by depressing the third plunger 52while the first two are also depressed. The plungers in this embodimentmay be depressed in any order to deploy the first, second, and the thirdmedical appliances since the string is not bound underneath thedepressed plungers but, is rather, able to slide back and forthunderneath the depressed plunger.

[0027] Advantages of this configuration include that the operator canreadily detect the number of medical appliances that have been deployedand that, as can be seen in FIG. 6, the user may use a single hand tohold the endoscope and to deploy the medical appliances. In analternative embodiment the plungers may be retained by some lockingmechanism after the plunger has been depressed into the valleys 58 sothat it is not necessary to hold down the plungers in order to deployseveral bands. Conversely, the plungers may be biased in an openposition to reduce the likelihood that the plunger will be errantlydepressed by a practitioner during a procedure.

[0028] An alternative embodiment of a means for affirmatively verifyingthat a specific medical appliance from a plurality of appliances hasbeen deployed 70, is illustrated in FIG. 7. This means 70 may be placedat the distal end of an endoscope and may be used to pull a string apredetermined distance in order to deploy a ligation band incommunication with the string from a ligation tip at the distal end ofthe endoscope. This means 70 may include a shaft 76, an opening 72, anda slidable handle 71 coupled to the shaft 76 and adapted to be slid overthe shaft 76. The handle 71 may also contain several slots 78 that maybe sized to secure a looped end 75 of a sting 701 that may be attachedto a plurality of ligation bands at the distal end of the endoscope orother device. Consequently, as the handle 71 is incrementally advanceddown the shaft 76 the string 701 may be pulled by that same incrementaldistance as the handle 71 is slid.

[0029] Alternatively, in another embodiment, rather than having thestring directly coupled to the ligating bands, a pulley system may beemployed that adjusts or modifies the distance that handle needs to bepulled before each ligation band is deployed. This pulley system ormechanical advantage system may increase the distance that the handleneeds to be pulled or conversely decrease the distance that the handleneeds to be pulled.

[0030] Also evident in FIG. 7 are a plurality of stops 73, 74, 77, and702 that protrude up from the shaft 76 and may be sized to arrest thetravel of the handle 71 as it slides down the body 76.

[0031] These stops may be integrally formed with the shaft 76 and may becompressible or incompressible. The compressible stops 73, 77, and 702in this embodiment may be designed so that they may be depressed toallow the handle 71 to be slid over them and down the shaft fromposition to position as indicated by arrows 702 in FIG. 7. Conversely,stop 74, which is fixed and incompressible in this embodiment, may actto prevent the handle 71 from sliding further down the body 76, thusacting as a block at the end of the handle 71. In addition, stops mayalso be used to arrest the travel of the handle 71 in the directionopposite to the arrows 702. An example of this type of stop is stop 79which is shown preventing the handle 71 from sliding closer to opening703 and obstructing the string 701 that protrudes from it. In thisembodiment, as well as the embodiments discussed above, the shaft orbody of the device may be made from rigid plastic, surgical grademetals, and other suitable materials.

[0032] Method and apparatus for deploying medical appliances from amedical appliance is provided. While several embodiments of the presentinvention have been described above other embodiments within the spiritand scope of the present invention are also plausible.

What is claimed is:
 1. An apparatus for selectively deploying one ormore sequentially positioned medical appliances from a portable medicaldevice to a target site, the apparatus comprising: a ligation tip havinga plurality of sequentially ordered deployable medical appliances incontact with its outside surface, the ligation tip having an internalpassage; a body having a channel, the channel in communication with theinternal passage of the ligation tip; a string passing through theinternal passage and the channel, the string being associated with atleast one of the medical appliances from the plurality of sequentiallyordered deployable medical appliances; and a means, coupled to thestring, for affirmatively verifying that the specific medical appliance,from the plurality of medical appliances, has been deployed.
 2. A systemfor selectively deploying one or more sequentially positioned medicalappliances from a portable medical device, having a passage through it,to a target site comprising: a flexible sheath having a channel, aninside surface, an outside surface, a distal end, and a proximal end; anexternal sealing plug positioned along the outside surface of the sheathbetween the distal end and the proximal end, the external sealing plughaving a passage sized to slidably couple the sheath to the externalsealing plug; and a plurality of strings positioned within the channelof the flexible sheath, wherein each string of the plurality of stringshas a first end and a second end, the first end of at least one stringcoupled to a pull, the pull having a unique marking to distinguish it,the second end of this at least one string in physical communicationwith a catch.
 3. The system of claim 2 further comprising: a stopperfixedly positioned on the outside surface of the sheath; and a ligationtip containing a plurality of deployable sequentially positioned medicalappliances and at least one deployment string, the deployment stringcoupled to the catch and at least one of the medical appliances.
 4. Thesystem of claim 3 wherein the pull includes a label identifying aspecific appliance.
 5. The system of claim 4 wherein the label containsa specific number or color.
 6. The system of claim 2 wherein the sealingplug contains threads sized to rotatably connect it to the medicaldevice.
 7. The system of claim 6 wherein the stopper is sized toprohibit it from being pulled through the passage of the sealing plug.8. The system of claim 2 wherein the sheath is polygonal and wherein theshape of the pull is associated with an appliance.
 9. The system ofclaim 2 wherein the sealing plug is compressible and is sized tocompressibly secure itself to an orifice of the medical device.
 10. Thesystem of claim 2 wherein the external sealing plug contains externalthreads sized to rotatably secure the plug to the medical device andwherein the medical device is an endoscope.
 11. The system of claim 2wherein the catch is a loop.
 12. A method for selectively deploying oneor more sequentially positioned medical appliances from a portablemedical device to a target site comprising: inserting into an entranceof a portable medical device a removeable cable system containing aplurality of strings, at least one string having a first end and asecond end, the first end coupled to a pull, the pull marked toassociate it with a specific deployable medical appliance, the secondend ending in a catch, the catch associated with the specific deployablemedical appliance, the plurality of strings encased within a sheath;advancing the removeable cable system along the longitudinal axis of theportable medical device; exposing a second end of at least one string ofthe removeable cable system from the orifice of the portable medicaldevice; connecting the second end of the at least one string to a secondstring, the second string coupled to a deployable medical appliance, thedeployable medical appliance positioned on a tip having a connecting endadapted to secure itself to the portable medical device; and installingthe tip on the portable medical device.
 13. The method of claim 12further comprising: positioning the distal end of the medical device ata target site; and pulling at least one pull to deploy a medicalappliance at the target site.
 14. An apparatus for selectively deployingone or more sequentially positioned medical appliances from a portablemedical device to a target site comprising: a body containing a variablelength string pathway, the pathway having an opening, the length of thepathway alterable through the introduction of a plunger into thepathway, the plunger slidably mounted in the body, the body adapted tobe secured to the medical device, the body containing an anchoring pointfor a string.
 15. The medical apparatus of claim 14 further comprising:a second plunger slidably mounted in the body and positioned to slideinto and elongate the pathway within the body.
 16. The medical apparatusof claim 14 wherein the body is trumpet-valve shaped.
 17. A method forselectively deploying one or more sequentially positioned medicalappliances from a portable medical device to a target site comprising:depressing a plunger of a body coupled to the medical device, the bodycontaining a string threaded through a string pathway, the stringsecured to the body, the length of the string pathway being altered bythe movement of the plunger, the string also in communication with adeployable medical appliance.
 18. The method of claim 17 furthercomprising: depressing a second plunger located in the body, the secondplunger altering the length of the string pathway.
 19. A medicalapparatus for selectively deploying one or more sequentially positionedmedical appliances from a portable medical device to a target sitecomprising: a shaft having a channel, an outside surface, an insidesurface, a proximal end, a distal end, and an opening; an externalhandle slidably coupled to the outside surface of the shaft; and a stopalong the surface of the shaft, the stop adapted to retard thelongitudinal movement of the handle along the shaft, the external handleconnected to a string coupled to a tip having a plurality of deployablemedical appliances.
 20. The medical apparatus of claim 19 furthercomprising: a second stop along the surface of the shaft, wherein thedeployable medical appliances are ligating bands.
 21. The medicalapparatus of claim 19, wherein the stop is integrally formed with theshaft.
 22. The medical apparatus of claim 19 wherein the stop iscompressible.
 23. A method for selectively deploying one or moresequentially positioned medical appliances from a portable medicaldevice to a target site comprising: inserting the proximal end of astring into an opening in a hollow shaft, the shaft having an outsidesurface, an inside surface, a proximal end, and a distal end; securingthe proximal end of the string to an external slidable handle, thehandle slidably coupled to the outside surface of the shaft, the distalend of the string in communication with a deployable medical appliance;and deploying a deployable medical appliance by sliding the handle untilit reaches a first stop.
 24. The method of claim 24, further comprising:sliding the handle axially along the shaft to reach a second stop.